Expired Study
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Buffalo, New York 14263


Purpose:

RATIONALE: Photodynamic therapy uses light and drugs that make tumor cells more sensitive to light to kill tumor cells. Photosensitizing drugs such as HPPH are absorbed by tumor cells and, when exposed to light, become active and kill the tumor cells. PURPOSE: Phase I trial to study the effectiveness of photodynamic therapy with HPPH in treating patients who have non-small cell lung cancer.


Study summary:

OBJECTIVES: - Determine the systemic and normal tissue toxicity of photodynamic therapy with HPPH in patients with early stage or centrally obstructing non-small cell lung cancer. - Determine, preliminarily, the efficacy of this regimen in these patients. OUTLINE: This is a dose-escalation study of HPPH. Patients receive HPPH IV over 1 hour on day 1. Patients undergo laser light therapy via bronchoscopy on day 3. Cohorts of 3-6 patients receive escalating doses of HPPH until the maximum tolerated dose (MTD) is determined. The MTD is defined as the dose preceding that at which 2 of 3 or 2 of 6 patients experience dose-limiting toxicity. Patients are followed for at least 6 months. PROJECTED ACCRUAL: Approximately 15-17 patients will be accrued for this study within 2 years.


Criteria:

DISEASE CHARACTERISTICS: - Histologically confirmed microinvasive or centrally obstructing non-small cell lung cancer - Squamous cell carcinoma - Adenocarcinoma - Large cell carcinoma PATIENT CHARACTERISTICS: Age: - 18 and over Performance status: - Karnofsky 50-100% OR - ECOG 0-2 Life expectancy: - Not specified Hematopoietic: - WBC at least 2,000/mm^3 - Platelet count at least 50,000/mm^3 Hepatic: - Bilirubin no greater than 3.0 mg/dL - Alkaline phosphatase no greater than 3 times upper limit of normal (ULN) - SGOT no greater than 3 times ULN - PT no greater than 1.5 times ULN Renal: - Creatinine no greater than 3.0 mg/dL Pulmonary: - No severe chronic obstructive pulmonary disease that would preclude study Other: - Not pregnant - Fertile patients must use effective contraception - No contraindications to bronchoscopy - No porphyria - No hypersensitivity to porphyrin or porphyrin-like compounds PRIOR CONCURRENT THERAPY: Biologic therapy: - Prior biologic therapy for lung cancer allowed Chemotherapy: - At least 4 weeks since prior chemotherapy - No concurrent chemotherapy Endocrine therapy: - Prior endocrine therapy for lung cancer allowed Radiotherapy: - At least 4 weeks since prior radiotherapy - No concurrent external beam radiotherapy Surgery: - No concurrent surgery Other: - Prior therapy for lung cancer allowed


NCT ID:

NCT00025571


Primary Contact:

Study Chair
Gregory M. Loewen, DO, FCCP
Roswell Park Cancer Institute


Backup Contact:

N/A


Location Contact:

Buffalo, New York 14263
United States



There is no listed contact information for this specific location.

Site Status: N/A


Data Source: ClinicalTrials.gov

Date Processed: September 24, 2017

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